Wednesday, March 30, 2011

/PRNewswire/ -- The Newborn Possibilities Fund, a grantmaking program established by Cord Blood Registry (CBR), today announced it will provide its first-ever grant to the Georgia Health Sciences University Foundation. The university's medical center is conducting the first FDA-regulated clinical trial evaluating cord blood stem cells as a medical intervention for cerebral palsy. The grant will provide financial support to help curb travel and other expenses for families with a child participating in the trial.

The study will include 40 children, ages 1 to 12 and will begin with a neurological exam. Then, half of the study participants will receive an infusion of their own cord blood while the other half receives a placebo. Three months later, the children will be evaluated without physicians knowing which group received the stem cell infusion. Afterward, children who didn't get their cord blood initially will receive an infusion. Children in the study will return three and six months later for evaluation, where researchers will assess their motor skills and neurological development.

"This is a very well-designed clinical study that will provide new insights into the potential of cord blood stem cells to help children recover from nerve tissue damage to the brain," said Heather Brown, vice president of scientific and medical affairs at CBR. "However, the study design requires a family to make trips at their own expense to the study center. The goal of The Newborn Possibilities Fund is to remove financial barriers that may prevent eligible children from participating in this cutting-edge research and receiving investigational treatments that may improve their quality of life."

The Newborn Possibilities Fund (NPF) was created to help advance clinical research investigating the use of a child's own cord blood stem cells as a treatment for conditions like cerebral palsy and traumatic brain injury. The NPF directs financial grants to non-profit organizations to help cover the cost of travel for families who have the chance to participate in FDA-regulated trials. The Fund is administered by Tides, a public charity, on behalf of CBR.

Patients who meet the inclusion criteria and are enrolled in the trial at Georgia Health Sciences University will be notified of the Newborn Possibilities Fund and have the opportunity to receive funds to use toward the cost of travel to Augusta, Georgia for the cord blood infusion procedure and required follow up visits.

"The hope for stem cells, really from the beginning, is that they might serve as some type of replacement for cells in the nervous system that have been destroyed or never developed properly," said Dr. James Carroll, professor and chief of pediatric neurology at Georgia Health Sciences University and principal investigator on the study. "The main goal of our research is to try to help improve the lives of children with cerebral palsy and find out if the method we're using is going to help these children in the future."

A growing body of research in animals has shown that infused stem cells help to initiate repair and induce healing in the brain. While the Georgia Health Sciences University is the first controlled clinical trial to be conducted, anecdotal reports from previous studies have shown marked improvement in children with cerebral palsy about three months after an initial infusion of cord blood, which led Dr. Carroll to design his trial.

Through generous donations, the Newborn Possibilities Fund hopes to provide financial support for additional trials already underway at leading research universities across the country. For more information on the program or to donate, please visit www.newbornpossibilities.com/donate.asp

Melanoma is the leading cause of death from skin disease. An estimated 68,130 new cases of melanoma were diagnosed in the United States during 2010 and about 8,700 people died from the disease, according to the National Cancer Institute.

"Late-stage melanoma is devastating, with very few treatment options for patients, none of which previously prolonged a patient's life," said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research. "Yervoy is the first therapy approved by the FDA to clearly demonstrate that patients with metastatic melanoma live longer by taking this treatment."

Yervoy is a monoclonal antibody that blocks a molecule known as cytotoxic T-lymphocyte antigen or CTLA-4. CTLA-4 may play a role in slowing down or turning off the body's immune system, affecting its ability to fight off cancerous cells. Yervoy may work by allowing the body's immune system to recognize, target, and attack cells in melanoma tumors. The drug is administered intravenously.

Yervoy's safety and effectiveness were established in a single international study of 676 patients with melanoma. All patients in the study had stopped responding to other FDA-approved or commonly used treatments for melanoma. In addition, participants had disease that had spread or that could not be surgically removed.

The study was designed to measure overall survival, the length of time from when this treatment started until a patient's death. The randomly assigned patients received Yervoy plus an experimental tumor vaccine called gp100, Yervoy alone, or the vaccine alone.

Those who received the combination of Yervoy plus the vaccine or Yervoy alone lived an average of about 10 months, while those who received only the experimental vaccine lived an average of 6.5 months.

Common side effects that can result from autoimmune reactions associated with Yervoy use include fatigue, diarrhea, skin rash, endocrine deficiencies (gland or hormone), and inflammation of the intestines (colitis). Severe to fatal autoimmune reactions were seen in 12.9 percent of patients treated with Yervoy. When severe side effects occurred, Yervoy was stopped and corticosteroid treatment was started. Not all patients responded to this treatment. Patients who did respond in some cases did not see any improvement for several weeks.

Due to the unusual and severe side effects associated with Yervoy, the therapy is being approved with a Risk Evaluation and Mitigation Strategy to inform health care professionals about these serious risks. A medication guide will also be provided to patients to inform them about the therapy's potential side effects.

Thursday, March 24, 2011

The Food and Drug Administration (FDA) today approved the use of Zostavax, a live attenuated virus vaccine, for the prevention of shingles in individuals 50 to 59 years of age. Zostavax is already approved for use in individuals 60 years of age and older.

In the United States shingles affects approximately 200,000 healthy people between the ages of 50 and 59, per year. It is a disease caused by the varicella-zoster virus, which is a virus in the herpes family and the same virus that causes chickenpox. After an attack of chickenpox, the virus lies dormant in certain nerves in the body. For reasons that are not fully understood, the virus can reappear in the form of shingles, more commonly in people with weakened immune systems and with aging.

"The likelihood of shingles increases with age. The availability of Zostavax to a younger age group provides an additional opportunity to prevent this often painful and debilitating disease" said Karen Midthun, M.D., director of FDA's Center for Biologics Evaluation and Research.

Shingles is characterized by a rash of blisters, which generally develop in a band on one side of the body and can cause severe pain that may last for weeks, and in some people, for months or years after the episode.

Approval was based on a multicenter study conducted in the United States and four other countries in approximately 22,000 people who were 50-59 years of age. Half received Zostavax and half received a placebo. Study participants were then monitored for at least one year to see if they developed shingles. Compared with placebo, Zostavax reduced the risk of developing shingles by approximately 70 percent.

The most common side effects observed in the study were redness, pain and swelling at the site of injection, and headache.

Zostavax was originally approved on May 26, 2006, for the prevention of shingles in individuals 60 years of age and older.

Zostavax is manufactured by Merck & Co. Inc., of Whitehouse Station, New Jersey.

Wednesday, March 23, 2011

/PRNewswire/ -- Obese teens may feel healthy, but blood tests show they have inflammation, insulin resistance, and high homocysteine levels, researchers report at the American Heart Association's Nutrition, Physical Activity and Metabolism/Cardiovascular Disease Epidemiology and Prevention 2011 Scientific Sessions.

"The metabolic abnormalities suggest that the process of developing heart disease has already started in these children, making it critical for them to make definitive lifestyle and diet changes," said Ashutosh Lal, M.D., senior author of the study and a pediatric hematologist at the Children's Hospital and Research Center Oakland in California.

Researchers compared the diets and blood test results of 33 obese youths (ages 11 to 19) with 19 age-matched youths of normal weight. Obesity in youths is a body mass index (BMI) higher than the 95th percentile of children the same age. Normal weight youths had a BMI below the 85th percentile. Body mass index is a measure of weight related to height. Two thirds of the participants in both groups were girls. All of the participants were receiving regular health maintenance care at an inner city clinic in Oakland.

Blood tests revealed that the obese teens had:

* C-reactive protein levels almost ten times higher than controls, indicating more inflammation in the body.
* Insulin resistance, a precursor to type 2 diabetes, with greater amounts of insulin needed to keep blood sugar levels normal.
* Homocysteine levels 62 percent higher than controls. High levels of the amino acid homocysteine are related to greater heart disease risk.
* Total glutathione levels 27.9 percent lower than controls, with oxidized glutathione levels 125 percent higher. A higher ratio of oxidized to non-oxidized glutathione indicates oxidative stress, an imbalance in the production of cell-damaging free radicals and the body's ability to neutralize them. Oxidative stress leads to more inflammation and an increase in blood vessel damage and stiffening.

"Looking at the numbers you would think these children might feel sick, but they did not," Lal said. "They are apparently feeling well, but there is a lot going on beneath the surface."

Dietary quality was poor in all the children – low in fresh produce, fiber, and dairy products. On questionnaires, obese and normal-weight children reported consuming similar amounts of grains, proteins, fats and total calories. However, the obese children reported significantly fewer servings of dairy products and tended towards fewer fruit servings. The obese children's diets were lower in potassium, vitamin C, vitamin D, and vitamin A, found in fortified dairy products and as well as in deeply colored fruits and vegetables.

With such poor dietary quality in both the obese and control groups, clinicians should pay more attention to what their young patients are eating, researchers said.

"Obese teens were consuming too few of the natural sources of anti-oxidants, fruits and vegetables, and may have increased antioxidant needs based on the inflammation associated with their extra adiposity," Lal said. "For their heart health, obese teens need to eat better, not just eat less."

Though the study's participants attended an inner city health clinic, researchers said the metabolic differences between obese and normal-weight teens would be found in all socioeconomic groups.

The children in the study were racially diverse. The obese group was 39 percent African-American, 30 percent non-African-American Hispanic, 18 percent Caucasian and 6 percent Asian and 7 percent other. The control group was 21 percent African-American, 5 percent Hispanic, 42 percent Caucasian, 21 percent Asian and 11 percent other.

This study was funded by the Clinical and Translational Science Institute, University of California, San Francisco, and the Bruce and Giovanna Ames Foundation.

Statements and conclusions of study authors that are presented at American Heart Association scientific meetings are solely those of the study authors and do not necessarily reflect association policy or position. The association makes no representation or warranty as to their accuracy or reliability. The association receives funding primarily from individuals; foundations and corporations (including pharmaceutical, device manufacturers and other companies) also make donations and fund specific association programs and events. The association has strict policies to prevent these relationships from influencing science content. Revenues from pharmaceutical and device corporations are available at www.heart.org/corporatefunding.

Tuesday, March 15, 2011

Join Grady Health Foundation as they kick-off their annual fundraising campaign with an evening at the Georgia Aquarium celebrating visionary philanthropist, Bernie Marcus, notable general surgeon and author, Dr. David Feliciano, inspiring mentor and Chief Nursing Officer, Dr. Rhonda Scott as well as next generation healer and Chief Surgical Resident, Dr. Carla Haack. Grady Health Foundation was formed to encourage corporations, foundations, and individual citizens to invest in the continued health and wellbeing of Atlanta through this vital public resource. This black-tie gala promises to be a unique tribute honoring a select group of healthcare heroes!

Benlysta is delivered directly into a vein (intravenous infusion) and is the first inhibitor designed to target B-lymphocyte stimulator (BLyS) protein, which may reduce the number of abnormal B cells thought to be a problem in lupus.

Prior to Benlysta, FDA last approved drugs to treat lupus, Plaquenil (hydroxychloroquine) and corticosteroids, in 1955. Aspirin was approved to treat lupus in 1948.

Lupus is a serious, potentially fatal, autoimmune disease that attacks healthy tissues. It disproportionately affects women, and usually develops between ages 15 and 44. The disease affects many parts of the body including the joints, the skin, kidneys, lungs, heart, and the brain. When common lupus symptoms appear (flare) they can present as swelling in the joints or joint pain, light sensitivity, fever, chest pain, hair loss, and fatigue.

Estimates vary on the number of lupus sufferers in the United States ranging from approximately 300,000 to 1.5 million people. People of all races can have the disease; however, African American women have a 3 times higher incidence (number of new cases) than Caucasian women.

“Benlysta, when used with existing therapies, may be an important new treatment approach for health care professionals and patients looking to help manage symptoms associated with this disease,” said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research.

Two clinical studies involving 1,684 patients with lupus demonstrated the safety and effectiveness of Benlysta. The studies diagnosed patients with active lupus and randomized them to receive Benlysta plus standard therapy, or an inactive infused solution (placebo) plus standard therapy. The studies excluded patients who had received prior B-cell targeted therapy or intravenous cyclophosphamide, and those who had active lupus involving the kidneys or central nervous system.

Patients treated with Benlysta and standard therapies experienced less disease activity than those who received a placebo and standard of care medicines. Results suggested, but did not definitively establish, that some patients had a reduced likelihood of severe flares, and some reduced their steroid doses.

African American patients and patients of African heritage participating in the two studies did not appear to respond to treatment with Benlysta. The studies lacked sufficient numbers to establish a definite conclusion. To address this concern, the sponsor has agreed to conduct an additional study of people with those backgrounds to further evaluate the safety and effectiveness of Benlysta for this subgroup of lupus patients.

Those receiving Benlysta during clinical studies reported more deaths and serious infections compared with placebo. The drug should not be administered with live vaccines. The manufacturer is required to provide a Medication Guide to inform patients of the risks associated with Benlysta.

The most common side effects in the studies included nausea, diarrhea, and fever (pyrexia). Patients also commonly experienced infusion reactions, so pre-treatment with an antihistamine should be considered.

Human Genome Sciences Inc., based in Rockville, Md., developed Benlysta and will co-market the drug in the United States with GlaxoSmithKline of Philadelphia.

Sunday, March 6, 2011

The U.S. Food and Drug Administration today (March 4) announced that monthly liver enzyme tests are no longer required for those taking Letairis tablets (ambrisentan), used to treat high blood pressure in the vessels that carry blood to the lungs (pulmonary arterial hypertension, or PAH).

Citing data from clinical trials and postmarket reports, the FDA said that the drug poses only a low risk of liver injury. Information related to potential serious liver injury and the need to monitor for such serious injury is being removed from the drug’s boxed warning.

In patients with PAH, Letairis slows the worsening of symptoms and improves the ability to exercise. Approved in 2007, Letairis is in a class of medications called endothelin receptor antagonists, which stop the action of endothelin, a substance that narrows blood vessels and prevents normal blood flow in those with PAH.

“We have concluded that monthly liver enzyme testing for patients taking Letairis, as previously noted in the boxed warning, is not necessary,” said Mary Ross Southworth, Pharm.D., deputy director for safety in the Division of Cardiovascular and Renal Products at the FDA’s Center for Drug Evaluation and Research. “Health care professionals should still continue to order liver enzyme tests when they consider it clinically indicated.”

Letairis was approved with a Risk Minimization Action Plan (RiskMAP) to manage liver damage and fetal malformation. The RiskMAP called for liver enzyme testing prior to treatment and monthly during treatment for all patients. It also required monthly pregnancy testing for women of childbearing potential because Letairis causes birth defects in animals, like other drugs in this class. The Letairis RiskMAP was converted to a Risk Evaluation and Mitigation Strategy in 2009.

The boxed warning on the risk of serious birth defects and the contraindication for use during pregnancy will remain in the labeling. Letairis will continue to be available only through a restricted distribution program called the Letairis Education and Access Program (LEAP). For women who can become pregnant, monthly pregnancy tests will still be required before Letairis is shipped.

The liver warnings were based on experience with other drugs in Letairis’ drug class, as well as a few observed instances of increased liver enzymes in people treated with Letairis. The FDA’s further evaluation has shown that rates of liver problems in Letairis-treated patients are consistent with rates within the general PAH population. In the controlled clinical trials, the rates of liver problems in Letairis-treated patients are similar to the rates in people receiving an inactive pill (placebo).

For a discussion of the FDA’s rationale and regulatory decisions regarding Letairis, refer to the Drug Safety Communication issued today.

People who take Letairis should not stop taking it without talking to their health care professional. Health care professionals should order and review tests for liver function as necessary based on the patient’s condition and history. Adverse events involving Letairis should be reported to the FDA MedWatch program1.

Friday, March 4, 2011

The U.S. Food and Drug Administration has expanded the use of Allergan’s LAP-BAND Adjustable Gastric Banding System, a device implanted around the upper part of the stomach to limit the amount of food that can be eaten at one time.

The Feb. 16, 2011, approval expands the use of the LAP-BAND to include obese individuals with a BMI of 30 to 34 who also have an existing condition related to their obesity.

The FDA approved the LAP-BAND in 2001 for use in severely obese patients with a body mass index (BMI) of at least 40, those with a BMI of at least 35 and who also have an existing severe condition related to their obesity, such as heart disease or diabetes, or those who are at least 100 pounds overweight. BMI is a general measure of body fat based on an individual’s weight and height.

The LAP-BAND is intended to be used for weight loss in adults who have not lost weight using non-surgical weight loss methods. The newly-approved indication is limited to patients with a BMI of 30 to 34 and at the highest risk of obesity-related complications. This represents a narrower indication than originally sought by Allergan. The company had also proposed to expand the indication to include people with a BMI of 35 to 39 and no obesity related condition. Patients using the LAP-BAND must be willing to make major changes to their lifestyle and eating habits.

“Obesity is a major public health concern in the United States,” said William Maisel, M.D., M.P.H., deputy director for science at the FDA’s Center for Devices and Radiological Health. “A healthy lifestyle and weight loss are keys to improvements in health and a person’s overall quality of life.”

Use of the LAP-BAND in patients with BMIs between 30 and 40 was examined in a U.S. study. Results showed that 80 percent of patients lost at least 30 percent of their excess weight and kept it off for one year. Some patients in the study lost no weight, while others lost more than 80 percent of their extra weight.

In the same study, more than 70 percent of patients experienced an adverse event related to LAP-BAND, most often vomiting and difficulty swallowing. The events ranged from mild to severe but most were mild and resolved quickly.

Seven out of 149 patients needed other procedures after implantation: four to remove the LAP-BAND, two for port revisions, and one to reposition the LAP-BAND.

The LAP-BAND works by limiting the amount of food that can be eaten at one time and increasing the time it takes for food to be digested, to help people eat less. It is placed around the upper part of the stomach during a surgical procedure. The band creates a small stomach pouch that holds a small amount of food.

The LAP-BAND should not be used in certain people, for example, those who are poor candidates for surgery, have certain stomach or intestinal disorders or an infection, take aspirin frequently, or are addicted to alcohol and/or drugs. It should also not be used in those not able or willing to follow dietary and other recommendations.

Tuesday, March 1, 2011

The U.S. Food and Drug Administration approved roflumilast, a pill taken daily to decrease the frequency of flare-ups (exacerbations) or worsening of symptoms from severe chronic obstructive pulmonary disease (COPD).

COPD is a serious lung disease that makes breathing difficult. Symptoms can include breathlessness, chronic cough and excessive phlegm. An exacerbation can last up to several weeks and result in lung function decline, increased risk of death, and may be associated with severe anxiety.

Cigarette smoking is the leading cause of COPD, according to the National Heart, Lung, and Blood Institute. COPD is the fourth leading cause of death in the United States.

Roflumilast, a new drug class for the treatment of COPD, is an inhibitor of an enzyme called phosphodiesterase type 4 (PDE-4). It is indicated for people with severe COPD to treat the symptoms of cough and excess mucus linked to bronchitis. Roflumilast is not intended to treat another form of COPD which involves primary emphysema.

“COPD is a serious disease that gets worse over time,” said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research. “New treatment options that reduce frequency of flare-ups or exacerbations are important in helping patients with COPD associated with chronic bronchitis and a history of exacerbations in managing this debilitating disease.”

The safety and effectiveness of roflumilast was demonstrated in two Phase 3 clinical studies that included more than 1,500 patients ages 40 and older who received roflumilast. Those treated had a history of COPD associated with chronic bronchitis and had experienced an exacerbation of the disease during the 12 months prior to beginning treatment.

The FDA approved roflumilast with a medication guide informing patients of the potential risks of mental health problems, including changes in mood, thinking, or behavior, as well as unexplained weight loss.

Roflumilast should not be used to treat sudden breathing problems (acute bronchospam), and is not recommended for people younger than 18 years. The most common side effects reported by those receiving roflumilast included diarrhea, nausea, headache, insomnia, back pain, decreased appetite, and dizziness.

Roflumilast is marketed by St. Louis-based Forest Pharmaceuticals, a subsidiary of Forest Laboratories.

We are often asked "Why 'hearsay'?" We included that word in our blog title because sometimes those promoting a product or health issue sound good, but later the info is found to be incorrect or even harmful. One day it's great to drink a glass of red wine for your health, the next it's taboo.

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